A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

Last updated: January 21, 2022
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Hypertriglyceridemia

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Treatment

N/A

Clinical Study ID

NCT03861039
17078
I8F-JE-GPGP
  • Ages > 20
  • All Genders

Study Summary

The purpose of this study is to determine the long-term safety of the study drug tirzepatide in combination with oral antihyperglycemic medications in participants with type 2 diabetes.

Eligibility Criteria

Inclusion

Inclusion Criteria: Participant must:

  • Have been diagnosed with type 2 diabetes mellitus based on the World HealthOrganization classification before the screening visit.
  • Have HbA1c ≥7.0% to <11.0%, as determined by the central laboratory at screening.
  • Have been taking sulfonylureas, biguanides, thiazolidinedione, alpha-glucosidaseinhibitor, glinides, or sodium-glucose cotransporter type 2 inhibitor monotherapy forat least 3 months before screening and have been on the following dose for at least 8weeks before screening.
  • Have body mass index (BMI) of ≥23 kilograms per meter squared at screening.
  • Be of stable weight (±5%) during 3 months preceding screening; and agree to notinitiate an intensive diet and/or exercise program during the study with the intent ofreducing body weight other than the lifestyle and dietary measures for diabetestreatment.

Exclusion

Exclusion Criteria: Participant must not:

  • Have type 1 diabetes mellitus.
  • Have had chronic or acute pancreatitis any time prior to study entry.
  • Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferativediabetic retinopathy requiring immediate or urgent treatment.
  • Have disorders associated with slowed emptying of the stomach, or have had any stomachsurgeries for the purpose of weight loss.
  • Have acute or chronic hepatitis, signs and symptoms of any other liver disease, orblood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participantswith nonalcoholic fatty liver disease (NAFLD) are eligible for participation in thistrial only if there ALT level is ≤3.0 the ULN for the reference range.
  • Have had a heart attack, stroke, or hospitalization for congestive heart failure inthe past 2 months.
  • Have a personal or family history of medullary thyroid carcinoma or personal historyof multiple endocrine neoplasia syndrome type 2.
  • Have been taking weight loss drugs, including over-the-counter medications during thelast 3 months.

Study Design

Total Participants: 443
Study Start date:
March 30, 2019
Estimated Completion Date:
February 16, 2021

Connect with a study center

  • Akaicho Clinic

    Chiba-shi, Chiba 260 0804
    Japan

    Site Not Available

  • Kashiwa hospital

    Kashiwa, Chiba 277-0825
    Japan

    Site Not Available

  • Manda Hospital

    Sapporo, Hokkaido 060-0062
    Japan

    Site Not Available

  • Miyanomori Hospital

    Sapporo, Hokkaido 064-8570
    Japan

    Site Not Available

  • Yuri Ono Clinic

    Sapporo, Hokkaido 060-0001
    Japan

    Site Not Available

  • Ikeda Hospital

    Amagasaki, Hyogo 661-0002
    Japan

    Site Not Available

  • Nakamoto Naika Clinic

    Mito, Ibaraki 310 0826
    Japan

    Site Not Available

  • Naka Memorial Clinic

    Naka, Ibaraki 311-0113
    Japan

    Site Not Available

  • Ohishi Naika Clinic

    Tsuchiura, Ibaraki 300-0835
    Japan

    Site Not Available

  • Takai Naika Clinic

    Kamakura, Kanagawa 247-0056
    Japan

    Site Not Available

  • Tsuruma Kaneshiro Diabetes Clinic

    Yamato, Kanagawa 242-0004
    Japan

    Site Not Available

  • H.E.C. Science Clinic

    Yokohama, Kanagawa 235-0045
    Japan

    Site Not Available

  • Yokohama Minoru Clinic

    Yokohama, Kanagawa 232-0064
    Japan

    Site Not Available

  • Takatsuki Red Cross Hospital

    Takatsuki, Osaka 569-1096
    Japan

    Site Not Available

  • Otsu City Hospital

    Otsu, Shiga 520-0804
    Japan

    Site Not Available

  • Wakakusa Clinic

    Shimotsuke, Tochigi 329-0433
    Japan

    Site Not Available

  • Seiwa Clinic

    Adachi-ku, Tokyo 123 0845
    Japan

    Site Not Available

  • HDC Atlas Clinic

    Chiyoda, Tokyo 102-0082
    Japan

    Site Not Available

  • Asahi Life Foundation Adult Disease Research Center

    Chuo-ku, Tokyo 103 0002
    Japan

    Site Not Available

  • Nihonbashi Sakura Clinic

    Chuo-ku, Tokyo 103-0025
    Japan

    Site Not Available

  • Tokyo Center Clinic

    Chuo-ku, Tokyo 103-0028
    Japan

    Site Not Available

  • Tokyo Clinical Trial Centre Fukuwa Clinic

    Chuo-ku, Tokyo 104-0031
    Japan

    Site Not Available

  • Tokyo-Eki Center-building Clinic

    Chuo-ku, Tokyo 103-0027
    Japan

    Site Not Available

  • Kanno Naika

    Mitaka, Tokyo 181 0013
    Japan

    Site Not Available

  • Shinjuku Research Park Clinic

    Shinjuku-Ku, Tokyo 169-0073
    Japan

    Site Not Available

  • Futata Tetsuhiro Clinic

    Fukuoka, 819 0006
    Japan

    Site Not Available

  • Jinnouchi Hospital

    Kumamoto, 862-0976
    Japan

    Site Not Available

  • Morinaga Ueno Clinic

    Kumamoto, 860 0863
    Japan

    Site Not Available

  • Abe Diabetes Clinic

    Oita, 870-0039
    Japan

    Site Not Available

  • Kansai Denryoku Hospital

    Osaka, 553-0003
    Japan

    Site Not Available

  • Kitada Clinic

    Osaka, 538 0044
    Japan

    Site Not Available

  • Saiseikai Noe Hospital

    Osaka, 536 0001
    Japan

    Site Not Available

  • Shizuoka City Shizuoka Hospital

    Shizuoka, 420-8630
    Japan

    Site Not Available

  • Suruga Clinic

    Shizuoka, 424-0855
    Japan

    Site Not Available

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